Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
8 study endpoints found for Urea Peroxide. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.
| Endpoint | Value | Route | Species | Study Type | Source |
|---|---|---|---|---|---|
| NOAEL | 100 ppm | oral | mouse | oral | REACH |
| NOAEL | 216 mg/kg bw/day | dermal | rat | dermal | REACH |
| NOAEL | 45000 ppm | oral | mouse | oral | REACH |
| NOAEL | 338.4 mg/kg bw/day | dermal | - | dermal | REACH |
| NOAEL | 45000 ppm | oral | rat | oral | REACH |
| NOAEL | 100 ppm | oral | - | oral | REACH |
| NOAEL | 45000 ppm | oral | - | oral | REACH |
| NOAEL | 45000 ppm | oral | - | oral | REACH |
Expert Verdict
Annex III restricted ingredient with maximum concentration limits applied (expressed as H2O2 equivalent). Must not be used in products for children. Requires specific labeling per Annex III conditions. Can cause oral mucosa irritation at higher concentrations and tooth sensitivity.
Frequently Asked Questions
Is Urea Peroxide safe in cosmetics?
Annex III restricted ingredient with maximum concentration limits applied (expressed as H2O2 equivalent). Must not be used in products for children. Requires specific labeling per Annex III conditions. Can cause oral mucosa irritation at higher concentrations and tooth sensitivity. The EU classifies Urea Peroxide as "restricted". Safety rating: MODERATE. 8 toxicological study endpoint(s) are available in our database.
Is Urea Peroxide allowed in the EU?
Urea Peroxide EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.
What does Urea Peroxide do in cosmetics?
Urea Peroxide functions as: Oral Care Agent (tooth bleaching), Oxidizing Agent. It is classified as a cosmetic ingredient in our database. CAS number: 124-43-6.
What is the Margin of Safety for Urea Peroxide?
adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.
What is the NOAEL for Urea Peroxide?
The NOAEL (No Observed Adverse Effect Level) for Urea Peroxide is 100 ppm based on a oral study via oral route in mouse. A total of 8 study endpoints are available. Source: REACH.
Compliance Tools
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Related Ingredients
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